NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052200030

Registered date:25/06/2020

fNIRS for CI mapping in patients with malformations

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedbilateral severe sensorineural hearing loss
Date of first enrollment30/07/2020
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)to determine parameters of electrical stimuli by the cochlear implant on the basis of results of fNIRS measurements in cochlear implant users with inner ear malformations

Outcome(s)

Primary OutcomePercentages of electrodes which successfully detect cochlear implant-induced neural responses
Secondary Outcome(1) duration of EABR and fNIRS measurements (2) thresholds determined by EABR, fNIRS, and behavioral measurements (3) adverse effects, diseases, and equipment troubles

Key inclusion & exclusion criteria

Age minimum>= 10month old
Age maximum< 18age old
GenderBoth
Include criteria(1) patients having inner ear or internal auditory canal (IAC) malformations and diagnosed as severe or profound hearing loss (2) age at testing ranges from 10 months old to 18 years old (3) patients who underwent cochlear implantation (4) patients who have signed to a written consent-form
Exclude criteria(1) patients who can not keep standing still for 3 minutes (2) patients who have severe dermatitis or infection on the head skin (3) patients who the principal investigator or research collaborators have decided to be inappropriate as the participants

Related Information

Contact

Public contact
Name Utako Shirono
Address 2-2 Minatojimaminamimachi, Chuo-ku, Kobe City, Hyogo Hyogo Japan 650-0047
Telephone +81-78-302-4321
E-mail ushirono@kcho.jp
Affiliation Kobe City Medical Center General Hospital
Scientific contact
Name Hiroshi Yamazaki
Address 2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe City, Hyogo Hyogo Japan 650-0047
Telephone +81-78-302-4321
E-mail hiroshi_yamazaki@kcho.jp
Affiliation Kobe City Medical Center General Hospital